NIDEK Co., Ltd., Hamacho Plant 9/24/13
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Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||10903 New Hampshire Avenue|
Silver Spring, MD 20993
September 24, 2013
VIA UNITED PARCEL SERVICE
President and CEO
NIDEK Co., Ltd., Ltd.
34-14 Maehama, Hiroishi, Gamagori
Aichi 443-0038, Japan
During an inspection of your firm located in Aichi, Japan, on May 20 through 23, 2013, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures Class I and II non-sterile laser devices. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), these products are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or function of the body.
This inspection revealed that these devices are adulterated within the meaning of section 501(h) of the Act, 21 U.S.C. § 351(h), in that the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the current good manufacturing practice requirements of the Quality System regulation found at Title 21, Code of Federal Regulations (CFR), Part 820.
Your firm’s responses dated July 17, 2013, and August 1, 2013, to the Form FDA 483 (FDA 483) were not reviewed because they were not received within fifteen business days of issuance of the FDA 483. The responses will be evaluated along with any other written material provided in response to the violations cited in this Warning Letter. These violations include, but are not limited to, the following:
1. Failure to establish and maintain procedures to include requirements for analyzing processes, work operations, concessions, quality audit reports, quality records, service records, complaints, returned product, and other sources of quality data to identify existing and potential causes of nonconforming product or other quality problems and to employ appropriate statistical methodology where necessary to detect recurring quality problems, as required by 21 CFR 820.100(a)(1).
For example, your firm’s Corrective and Preventive Action Procedure (CAPA), Document #DQF042, Revision H, only addresses whether or not a CAPA should be initiated for each individual finding cited from external audits. The procedure fails to address other sources of quality data (such as complaints, in-process nonconformities, etc.) to be examined methodologically in order to identify existing and potential causes of non‑conforming product, or other quality problems.
2. Failure to establish and maintain procedures for finished device acceptance to ensure that each production run, lot, or batch of finished devices meets acceptance criteria, as required by 21 CFR 820.80(d).
For example, your firm’s GYC-1000 (Green Laser Photocoagulator System) Final Inspection Procedure, Document #QQJ080B, is not adequate because it allows the technician performing the final inspections to decide whether or not to perform some of the final inspection tests. The technician could simply write down the results from the Assembly Inspection Record or the Post Adjustment In-Process Inspection Record. The procedure does not require the technician performing the final inspection to indicate whether the results were copied or actually performed by the technician at the final inspection.
3. Failure to establish and maintain procedures to control all documents that are required by this part, as required by 21 CFR 820.40.
For example, your firm’s Document Control Procedure, Document #HWF002J, indicates that documents shall be created, approved, and distributed with the appropriate version to the responsible division. This procedure is applicable to document creation, revision, and discontinuation. However, the following Green Laser Photocoagulator System (Model GYC-1000) production procedures were modified (via handwritten) without being subject to document controls:
- GYC-4 Assembly Procedure (for (b)(4) Adjustments), Document # 17164-ADJ1-001, Version C1
- GYC-4 Assembly Procedure (for (b)(4) Adjustments), Document #17164-ADJ2-001, Version B
- GYC-4 Assembly Procedure (for (b)(4) Adjustments), Document # 17164-ADJ3-001, Version C
- GYC-4 Assembly Procedure (for (b)(4)), Document # 17164-OU20-001, Version A
4. Failure to maintain complaint files and establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 CFR 820.198(a).
For example, your firm’s Complaint Handling Procedure, Document #DQF040Q, indicates that the procedure is applicable to all instruments sold (b)(4) pertaining to: complaints, quality, effectiveness, safety from customers, regulatory agencies, websites, and other sources. However, from 2010 to 2012, your firm received a total of (b)(4) forms from its initial importer and distributor. (b)(4) of these (b)(4) forms received by your firm were evaluated to determine whether the information included on the forms were medical device reportable events and whether failure investigations were necessary.
5. Failure to control labeling and packaging operations to prevent labeling mixups. The label and labeling used for each production unite, lot, or batch shall be documented in the device history record (DHR), as required by 21 CFR 820.120(d).
For example, your firm’s Quality Record Control Procedure, Document #HQF101L, requires the primary identification label and labeling used, device identification, and control number used, to be included or referenced in the DHR. However, (b)(4) DHRs from September 2011 through May 2013 (pertaining to the Green Laser Photocoagulator System - Model GYC-1000) were selected for review by the FDA investigator during the inspection. (b)(4) of the (b)(4) DHRs documented the label and labeling used for each production unit.
6. Failure of management with executive responsibility to review the suitability and effectiveness of the quality system at defined intervals and with sufficient frequency according to established procedures to ensure that the quality system satisfies the requirements of this part and the manufacturer’s established quality policy and objectives, as required by 21 CFR 820.20(c).
For example, your firm has yet to establish a management review procedure.
The U.S. federal agencies may be advised of the issuance of Warning Letters about devices so that they may take this information into account when considering the award of contracts. Additionally, premarket approval applications for Class III devices to which the Quality System regulation deviations are reasonably related will not be approved until the violations have been corrected. Requests for Certificates to Foreign Governments will not be granted until the violations related to the subject devices have been corrected.
Please notify this office in writing within fifteen business days from the date you receive this letter of the specific steps your firm has taken to correct the noted violations, including an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again. Include documentation of the corrections and/or corrective action (including any systemic corrective actions) that your firm has taken. If your firm’s planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of those activities. If corrections and/or corrective actions cannot be completed within fifteen business days, state the reason for the delay and the time within which these activities will be completed. Please provide a translation of documentation not in English to facilitate our review.
Your firm’s response should be sent to: Food and Drug Administration, Center for Devices and Radiological Health, Office of Compliance, Field Operations Branch, White Oak Building 66, Rm 2609, 10903 New Hampshire Ave., Silver Spring, MD 20993. Refer to CMS case #410944 when replying. If you have any questions about the contents of this letter, please contact LaShanda Long, Branch Chief, General Surgery Devices Branch at (301) 796-5770 or (301) 847-8137.
Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm’s facility. It is your firm’s responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the Inspectional Observations, FDA 483, issued at the close of the inspection may be symptomatic of serious problems in your firm’s manufacturing and quality management systems. Your firm should investigate and determine the causes of the violations, and take prompt actions to correct the violations and bring the products into compliance.
Steven D. Silverman
Office of Compliance
Center for Devices and